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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00242879




Registration number
NCT00242879
Ethics application status
Date submitted
19/10/2005
Date registered
21/10/2005
Date last updated
30/05/2017

Titles & IDs
Public title
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
Scientific title
Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen
Secondary ID [1] 0 0
HPR20001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus I 0 0
HIV-1 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Physician determined comparator PI + ritonavir
Treatment: Drugs - GW640385 + ritonavir

Treatment: Drugs: Physician determined comparator PI + ritonavir


Treatment: Drugs: GW640385 + ritonavir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time averaged change in plasma HIV-1 RNA over 16 wks
Timepoint [1] 0 0
Primary outcome [2] 0 0
Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels
Timepoint [2] 0 0
Primary outcome [3] 0 0
Change in laboratory parameters
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Assessments of HIV viral load changes
Timepoint [1] 0 0
Secondary outcome [2] 0 0
GW640385 and RTV pharmacokinetic measurements
Timepoint [2] 0 0
Secondary outcome [3] 0 0
The incidence of adverse events
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Changes in laboratory measurements
Timepoint [4] 0 0
Secondary outcome [5] 0 0
ECG measurements
Timepoint [5] 0 0
Secondary outcome [6] 0 0
HIV viral resistance assessment
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Immunologic measures
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- 18+ years of age (or =16 years of age for non-EU countries, according to local
requirements).

- HIV-1 infected subjects.

- Females must be of either non-childbearing potential or have a negative pregnancy test
at Screening and agree to use a protocol approved method of contraception.

- Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.

- Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of
Screening.

- Subjects must have been receiving the same anti-HIV medicines that they are on
currently for at least 8 weeks prior to Screening; these anti-HIV medicines will
include a single protease inhibitor (PI) in combination with a low dose of ritonavir
(i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.

- Able to understand and follow protocol requirements, instructions and protocol-stated
restrictions.

- Be willing and able to provide signed and dated written informed consent prior to
study entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.

- Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse
transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.

- Active CDC Class C disease at screening.

- Pregnant or breastfeeding women.

- Protocol-specified laboratory abnormalities at Screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [3] 0 0
GSK Investigational Site - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
State/province [15] 0 0
South Carolina
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United States of America
State/province [16] 0 0
Texas
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United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
La Roche Sur Yon cedex 9
Country [24] 0 0
France
State/province [24] 0 0
Lyon Cedex 02
Country [25] 0 0
France
State/province [25] 0 0
Lyon Cedex 03
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Paris Cedex 10
Country [28] 0 0
France
State/province [28] 0 0
Paris Cedex 12
Country [29] 0 0
Germany
State/province [29] 0 0
Bayern
Country [30] 0 0
Germany
State/province [30] 0 0
Hessen
Country [31] 0 0
Germany
State/province [31] 0 0
Nordrhein-Westfalen
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Italy
State/province [34] 0 0
Emilia-Romagna
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
Country [36] 0 0
Italy
State/province [36] 0 0
Piemonte
Country [37] 0 0
Italy
State/province [37] 0 0
Puglia
Country [38] 0 0
Italy
State/province [38] 0 0
Toscana
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Portugal
State/province [39] 0 0
Cascais
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Portugal
State/province [40] 0 0
Lisboa
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Puerto Rico
State/province [41] 0 0
Ponce
Country [42] 0 0
Puerto Rico
State/province [42] 0 0
San Juan
Country [43] 0 0
Romania
State/province [43] 0 0
Bucharest
Country [44] 0 0
Romania
State/province [44] 0 0
Constanta
Country [45] 0 0
Romania
State/province [45] 0 0
Iasi
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ViiV Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a two phase study (randomised and non-randomised phase). The randomised phase will
initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current
background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor
(PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy.
Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of
the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on
resistance testing at screening. Subjects will remain in the randomized phase on one of these
4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the
randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies.
After dose selection subjects will move to the non-randomised phase of the study. In the
non-randomised phase subjects who are receiving GW640385 will be assigned to final selected
dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral
activity.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00242879
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00242879